Status:
TERMINATED
Comparison of Actifuse ABX and Local Bone in Spinal Surgery
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Scoliosis
Kyphosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study is being done to compare people who had a standard of care spinal fusion using part of their local bone graft (a small amount of bone from the region of the spine where the fusion is occurr...
Detailed Description
The current method for posterolateral lumbar fusion surgeries utilizes autograft bone typically derived from the patient's iliac crest. However, complications have been reported concerning the use of ...
Eligibility Criteria
Inclusion
- Patient aged 18 to 80
- Patient received primary diagnosis of adult spinal deformity (with fusion of \>2 levels)
- Patient is a candidate for multi-level posterior lumbar fusion
- Patients that do not meet any of the exclusion criteria
Exclusion
- Non-English speaker
- Current Smoker
- Prisoner
- Patient with any of the following:
- Severe degenerative disease Inflammatory bone disease (e.g. osteomyelitis) Metabolic bone disease Radiation bone therapy Existing acute or chronic infections Abnormal calcium metabolism Hypocalcaemia Severe vascular or neurological disease Cardiovascular disease precluding elective surgery Uncontrolled diabetes Severely impaired renal function Documented renal disease Malignant tumors Pregnant or nursing
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01852747
Start Date
March 1 2013
End Date
January 1 2016
Last Update
April 28 2017
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43203